MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability.

Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.

Study Overview

• Status: Completed
• Conditions: Acute Compartment Syndrome
• Intervention / Treatment: Device: MY01 - Continuous Compartmental Pressure Monitor

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cooper Jefferson; Phone Number: 7057902959; Email: cooper.jefferson@nxtsens.com
• Study Contact Backup: Name: Mary Amedeo; Phone Number: 43386 (514) 934-1934; Email: mary.amedeo@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men or women, aged 18 years of age and older
• Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
• Mentally fit to provide informed consent

Exclusion Criteria:

• Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
• Infected wounds; infected fractures
• Patients who present with ACS requiring urgent surgical fasciotomy
• Patients who cannot consent to trial
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MY01 Device; Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure	Device: MY01 - Continuous Compartmental Pressure Monitor; Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical ease with which the new compartment pressure monitor was inserted into compartment.	At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you the device functioned adequately?" [0 = not confident] - [10 = very confident]. The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 10 should be considered a very positive scenario, whereas a record of 0 should indicate a very negative scenario.	24-48 hours following device insertion
Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.	At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate in a Yes or No question "Did the MY01 Application remote data display work properly?" [Yes] or [No].	24-48 hours following device insertion
The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.	Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's [Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia]), and compared against the pressure readout [mmHG] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.	24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.	Should surgical fasciotomy be deemed necessary to release pent up pressure in the patients muscle compartment, the continuous pressure read-outs [mmHG] derived from the device will be compared against the timeframe when the decision to conduct fasciotomy was made.	24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Short-term outcomes of the patient following continuous pressure monitoring	Survey and tabulation of data from patient clinical findings.	24-48 hours following device insertion.

Collaborators and Investigators

• Sponsor: MY01 Inc.
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre; Hopital du Sacre-Coeur de Montreal
• Investigators: Principal Investigator: Mitchell Bernstein, MD, Staff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute Compartment Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• Other Study ID Numbers: MY01 - QC - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No